Dear group,
I have a question about the definition about raw data.
We as QAU work in a research and development environment (GMP) and
would like to make a general definition for raw data for the
concerning departments. Because some departments have an EDMS in use
they have already a kind of definition of raw data which fits their
need. But I am not sure about the correctness of that definition and
if it will be accepted by governances as FDA.
The definition is that the "first human readable data" is considered
as raw data. This are are in most cases PDF versions of electronic
reports. The data that was necessary for making those PDF's is not
considered as raw data (direct instrument data, metadata). We know
that it is not possible to reprocess data afterwards because this
data has no GMP guarantee. But this is no GMP risk but a business
risk what we accept.
I know the general opinion is to store all the data from te beginning
till the end, as instrument data, meta data, reprocessing data and so
on. But in practice it is very hard to store this data on a secure
and logical way and to hold it accessable for the future. In 10 to 20
years computer equipment changes a lot and who can guarantee it can
be used over 20 years with the current equipment.
So I personally see the advantages in the statement of the first
readable data considered as raw data but I am not sure if this will
be accepted by FDA or other governances.
Because we are talking about electronic data we will apply the 21 CR
Part 11 rules for it because this data has a direct GMP value for our
business.
It would be very helpful for me tho know your opinion in this case.
Best regards and many thanks for your time,
Pedro van den Acker
Ps. I already posted this question in the general GMP group but
afterwards I found this group which is more suitable. Sorry for the
crosspost.
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Pedro van den Acker
pedro.vandenacker@organon.com
NV Organon
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